Bio-equivalence Study

Bioequivalence Clinical Trial

Official title:

Comparison of Bioavailability of Three Different Vitamin K2 Formulations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01638143
• Other study ID #: 10-3-017
• Status: Completed
• Phase: N/A
• First received: July 9, 2012
• Last updated: July 10, 2012
• Start date: November 2010
• Est. completion date: August 2011

Study information

• Verified date: July 2012
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to compare absorption of vitamin K2 (menaquinone-7) after intake of three different vitamin K2 supplements.

Description:

Several manufacturers are producing vitamin K2 raw material in different forms, namely oil and powder. To ensure bioequivalence of different vitamin K2 sources, the investigators are interested to compare the bioavailability of three different vitamin K2 formulations that are already commercially available. Two different oils and one powder product will be compared in this randomized cross-over trial. The investigators hypothesize that different vitamin K2 sources give no differences in bioavailability of vitamin K2.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• Healthy men and women, aged between 20 and 40 years

• Normal body weight and height (18.5 kg/m2 < BMI < 30 kg/m2)

• Stable body weight (weight gain or loss < 3 kg in past 3 mo)

• Written consent to take part in the study

• Agreement to adhere to dietary restrictions required by the protocol

Exclusion Criteria:

• Abuse of drugs and/or alcohol

• Use of vitamin supplements containing vitamin K

• Soy allergy

• Pregnancy

• a history of) metabolic or gastrointestinal diseases including hepatic disorders

• Chronic degenerative and/or inflammatory diseases, e.g. diabetes mellitus, renal failure

• Use of oral anticoagulants

• Corticoid treatment

• Subjects with anaemia or subjects who recently donated blood or plasma

• Systemic treatment or topical treatment likely to interfere with coagulation metabolism (salicylates, antibiotics)

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bioavailability
• Bioequivalence

Intervention

Dietary Supplement:
• MenaQ7 M-1500 capsules
The study participants will receive three different types of capsules as a single dose (75 µg of MK-7/day): MenaQ7 M-1500 capsule Gnosis P-1000 capsule Gnosis M-1500 capsule Every two weeks, participants switch to another type of capsule; the washout period will therefore be two weeks.
• Gnosis P-1000 capsules
The study participants will receive three different types of capsules as a single dose (75 µg of MK-7/day): MenaQ7 M-1500 capsule Gnosis P-1000 capsule Gnosis M-1500 capsule Every two weeks, participants switch to another type of capsule; the washout period will therefore be two weeks.
• Gnosis M-1500 capsules
The study participants will receive three different types of capsules as a single dose (75 µg of MK-7/day): MenaQ7 M-1500 capsule Gnosis P-1000 capsule Gnosis M-1500 capsule Every two weeks, participants switch to another type of capsule; the washout period will therefore be two weeks.

Locations

Country	Name	City	State
Netherlands	VitaK BV / Maastricht University Medical Center	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MK-7 absorption profiles	The purpose of this study is to compare the MK-7 absorption profiles after intake of three different vitamin K2 (MK-7) products that are already on the market. The main study parameter is therefore the calculated AUC value from the individual MK-7 absorption profiles.	9 weeks	No